A safety data sheet (SDS) is an established hazard communication tool in the chemical industry, for which no comparable or mandated document exists in the biotherapeutics sector yet is increasingly requested by the supply chain. As the cell and gene therapy (CGT) field expands, industry leaders and members of BioPhorum have identified a growing need to address this gap in communication around the unique occupational health and safety risks posed by CGT materials and products.
This new paper, An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet, provides you with a best practice for communicating workplace hazards, assessing the unique risks posed by these biological materials, and can help in creating exposure control plans specific to the workplace hazards.
Published in the Journal of Applied Biosafety, it contains 16 narrative sections ranging from hazard identification and composition/information on ingredients, to disposal considerations and transport information. If you are an SDS author, these provide useful context and background details, followed by a table that includes example information. There is also a downloadable template that you can use to communicate workplace hazards and assess the risks posed by CGT materials, available from the BioPhorum website.
The paper includes information on conducting a workplace risk assessment and communicating the unique hazards posed by potential exposures to CGT materials. It is based on assumptions of a maximum Biosafety Level 2.
Example use cases include:
- Transport of CGT bioactive product and intermediates across sites during R&D, manufacturing, or testing processes
- Technical transfer of CGT bioactive products and intermediates between client and contract manufacturing organization
- Operations in the R&D labs, manufacturing plants, packaging, and clinical and healthcare settings.
It is aimed at those handling and producing these materials, as well as collaborators, contractors, or operations sites receiving and handling the CGT material. However, it may also be helpful as a reference for other biotherapeutic modalities such as protein therapies, mRNA, and plasmids.
With no established tool in the field, this guide contains industry best practices with aspirations of becoming a standard communication for workplace hazards unique to CGT biological materials and products. For more information, contact Rachel Hodges, Senior Global Change Facilitator, at rachel.hodges@biopho